eszopiclone (Oral route)

Commonly used brand name(s)

In the U.S.

Lunesta

Available Dosage Forms:

Tablet

Therapeutic Class: Nonbarbiturate Hypnotic

Uses For eszopiclone

Eszopiclone is used to treat insomnia (trouble sleeping). It belongs to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system. Eszopiclone helps you get to sleep faster and sleep through the night.

Before Using eszopiclone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For eszopiclone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to eszopiclone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of eszopiclone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of eszopiclone in the elderly. However, dizziness, confusion, clumsiness, or unsteadiness are more likely to occur in the elderly, who may require a lower dose to help reduce unwanted effects.

Pregnancy

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking eszopiclone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using eszopiclone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Sodium Oxybate

Using eszopiclone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfentanil

Boceprevir

Bromazepam

Bromopride

Buprenorphine

Butorphanol

Carbinoxamine

Clarithromycin

Cobicistat

Codeine

Conivaptan

Dihydrocodeine

Fentanyl

Flibanserin

Flumazenil

Fospropofol

Hydrocodone

Hydromorphone

Idelalisib

Indinavir

Itraconazole

Ketoconazole

Lopinavir

Meclizine

Meperidine

Methadone

Morphine

Morphine Sulfate Liposome

Nefazodone

Nelfinavir

Oxycodone

Oxymorphone

Pentazocine

Periciazine

Posaconazole

Propofol

Remifentanil

Ritonavir

Saquinavir

Sufentanil

Tapentadol

Telaprevir

Telithromycin

Tramadol

Voriconazole

Zolpidem

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using eszopiclone with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use eszopiclone, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Using eszopiclone with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use eszopiclone, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of eszopiclone. Make sure you tell your doctor if you have any other medical problems, especially:

Alcohol abuse, history of or

Drug abuse or addiction, history of—May cause side effects to become worse.

Breathing problems or lung disease or

Depression, history of or

Mood or behavior changes, history of—Use with caution. May make these conditions worse.

Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of eszopiclone

Take eszopiclone only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).

eszopiclone should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take eszopiclone just before going to bed, when you are ready to go to sleep. eszopiclone works very quickly to put you to sleep.

Do not take eszopiclone when your schedule does not permit you to get a full night's sleep (8 hours). If you must wake up before this, you may continue to feel drowsy and have memory problems.

Swallow the tablet whole. Do not break, crush, or chew it.

Do not take eszopiclone with or immediately after a heavy, high-fat meal.

Dosing

The dose of eszopiclone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of eszopiclone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For insomnia:

Adults—At first, 1 milligram (mg) at bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3 mg per day.

Older adults—At first, 1 mg at bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2 mg per day.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of eszopiclone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using eszopiclone

It is very important that your doctor check your progress at regular visits to make sure eszopiclone is working properly. Blood tests may be needed to check for any unwanted effects.

eszopiclone may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.

If you think you need to take eszopiclone for more than 2 weeks, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.

eszopiclone will add to the effects of alcohol and other CNS depressants (medicines that makes you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using eszopiclone.

eszopiclone may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though eszopiclone is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to eszopiclone before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or not able to see well.

If you develop any unusual and strange thoughts or behavior while you are taking eszopiclone, be sure to discuss it with your doctor. Some changes that have occurred in people taking eszopiclone are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Eszopiclone may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using eszopiclone.

If you will be taking eszopiclone for a long time, do not stop taking it without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Stopping eszopiclone suddenly may cause withdrawal side effects.

After taking eszopiclone for insomnia, you may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking it.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

eszopiclone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Cough or hoarseness

fever or chills

lower back or side pain

painful or difficult urination

sleepiness or unusual drowsiness

Less common

Bladder pain

bloody or cloudy urine

cold flu-like symptoms

confusion

difficult, burning, or painful urination

discouragement

fear or nervousness

feeling sad or empty

frequent urge to urinate

irritability

lack of appetite

loss of interest or pleasure

nerve pain

seeing, hearing, or feeling things that are not there

tiredness

trouble concentrating

trouble sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

bad, unusual, or unpleasant (after) taste

belching

change in taste

dizziness

dry mouth

headache

heartburn

indigestion

nausea

pain

stomach discomfort, upset, or pain

Less common

Abnormal dreams

accidental injury

decreased interest in sexual intercourse

diarrhea

inability to have or keep an erection

pain, cramps, or heavy bleeding (females)

rash

swelling of the breasts or breast soreness (in both males and females)

vomiting

Incidence not known

Loss of memory

problems with memory

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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